MedPath
FDA Product

Minocycline hydrochloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Minocycline hydrochloride

68382-316

Regulatory Information

68382-316

ANDA063011

C73584

October 8, 2022

USA

Minocycline Hydrochloride Capsules, USP

HUMAN PRESCRIPTION DRUG LABEL

5

Company Information

156861945

Active Ingredients

MINOCYCLINE HYDROCHLORIDE

Quantity: 50 mg in 1 1

Code: 0020414E5U

Class Code: ACTIM

ALUMINUM OXIDE

Code: LMI26O6933

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

D&C RED NO. 33

Code: 9DBA0SBB0L

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

FD&C RED NO. 3

Code: PN2ZH5LOQY

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

MINOCYCLINE

Code: FYY3R43WGO

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